Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age56-85
SponsorNatalie Denburg
About this trial
The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests.
AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
between ages of 56-85 years
all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);
all participants must have a clinical dementia rating (CDR) Sum of boxes <1;
need to be willing to undergo CSF LP on two occasions over the course of their participation,
Disqualifiers
CDR>=1, clinically significant depression/anxiety (GDS>=9; GAI>=9 ),
Participants who are on any of the following medications will be excluded: Fluvoxamine (Luvox)/ Fluoxetine (Prozac), Nifedipine (a blood pressure medication), all anti-coagulants (e.g. Warfarin, Coumadin, Heparin, , Lovenox, Xarelto, Pradaxa, etc.), anti-seizure drugs (e.g. Acetazolamide, Carbamazepine, Clobazam, Clonazepam, Gabapentin, etc.), muscle relaxants (e.g.Baclofen, Valium/ diazepam, Flexeril, etc.), or narcotic pain relievers (e.g.Codeine, Tramadol, Hydrocodone, Demerol, etc).
Trial design
Design model
Parallel
Treatments tested in this trial
melatonin
Dietary supplement5mg of melatonin-otc 30 minutes before sleep
placebo
Other interventionplacebo 30 minutes before sleep
Treatment groups
230 Participants
are divided into 4 treatment groupsGroup A: MCI+ Melatonin 5mgExperimental treatment 1 intervention
Group B: MCI+ placeboPlacebo comparator 1 intervention
Group C: MCI- Melatonin 5mgExperimental treatment 1 intervention
Group D: MCI- placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Episodic memory
Composite episodic memory performance scores will be computed based on the following tests: Auditory Verbal Learning Test (AVLT), Free \& Cued Selective Reminding Test (FCSRT), Repeatable Battery for the Assessment of Neuropsychological Status (Story memory) at the week-8, week-16, and week-44 visits. Alternate forms will be used to assess performance in each of these tests across these visits to minimize practice effects. Composite scores at week-16 and week-44 visits will reference the pretreatment group mean and standard deviations to permit the detection of deviation from pre-treatment levels.
Time frame
Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.Secondary outcomes
1
Overall cognitive function
Composite performance scores will be computed based on the following cognitive tests: AVLT, FCSRT, RBANS-Story, Benton Visual Retention Test (BVRT), Trail Making Test (PartsA\&B), and Controlled Oral Word Association (COWA) at the week-8, week-16, and week-44 visits. Alternate forms will be used to assess performance in each of these tests, when available, across these visits to minimize practice effects. Composite scores at week-16 and week-44 visits will reference the pretreatment group mean and standard deviations to permit the detection of deviation from pre-treatment levels.
Time frame
Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.2
p-tau/Aβ42 ratio
Cerebrospinal values from lumbar puncture
Time frame
Assessed at pre-treatment (week-8) and one post-treatment occasion (week-44)3
t-tau
Cerebrospinal values from lumbar puncture
Time frame
Assessed at pre-treatment (week-8) and one post-treatment occasion (week-44)4
Sleep Efficiency
Daily Sleep efficiency values obtained from actigraphy during the wash-out period (weeks 1 to 8) and sleep efficiency values obtained from actigraphy during week-8 to week-16 when participants are on placebo or the active arm.
Time frame
Daily from actigraphy in the pre-treatment phase which lasts 8 weeks (phase#1) and daily from actigraphy in the post-treatment phase from week-9 to week-16 (phase#2).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Natalie Denburg
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov